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Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open-label, blinded-endpoint, randomised controlled study (PRIME-V study)

Masaya Koshizaka, Ko Ishikawa, Ryoichi Ishibashi, Yoshiro Maezawa, Kenichi Sakamoto, Daigaku Uchida, Susumu Nakamura, Masaya Yamaga, Hidetaka Yokoh, Akina Kobayashi, Shunichiro Onishi, Kazuki Kobayashi, Jun Ogino, Naotake Hashimoto, Hirotake Tokuyama, Fumio Shimada, Emi Ohara, Takahiro Ishikawa, Mayumi Shoji, Shintaro Ide, Kana Ide, Yusuke Baba, Akiko Hattori, Takumi Kitamoto, Takuro Horikoshi, Ryouta Shimofusa, Sho Takahashi, Kengo Nagashima, Yasunori Sato, Minoru Takemoto, L Kristin Newby, Koutaro Yokote
Diabetes, Obesity & Metabolism 2019 April 17
A prospective, multicentre, open-label, blinded-endpoint, randomised controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium-dependent glucose transporter-2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7-10%, and BMI ≥22 kg/m2 . Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000-1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percent reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (-12.06% vs. -3.65%, P=0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)-resistance, and increased HDL-cholesterol levels. Metformin significantly reduced HbA1c and LDL-cholesterol levels and increased HOMA-beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase-4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors. This article is protected by copyright. All rights reserved.


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